A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-04-30

Brief Summary

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This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.

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Detailed Description

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Conditions

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Infertility Induction of Ovulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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T-R (Test-Reference drug)

DA-3803 Injection is injected first and Ovidrel liquid injection is injected after 3-week period

Group Type EXPERIMENTAL

T-R (Test-Reference drug)

Intervention Type DRUG

R-T (Reference-Test drug)

Ovidrel liquid injection is injected first and DA-3803 Injection is injected after 3-week period

Group Type EXPERIMENTAL

R-T (Reference-Test drug)

Intervention Type DRUG

Interventions

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T-R (Test-Reference drug)

Intervention Type DRUG

R-T (Reference-Test drug)

Intervention Type DRUG

Other Intervention Names

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Drug: DA-3803 (Test drug) Drug: Ovidrel liquid injection (Referecne drug) Drug: Ovidrel liquid injection (Referecne drug) Drug: DA-3803 (Test drug)

Eligibility Criteria

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Inclusion Criteria

* No medical history relating to the alimentary system, liver system, heart system, haematological disease
* Ideal body weight +/- 20%

Exclusion Criteria

* acute disease within 28 days
* medical history that might affect the absorption, distribution, secretion, metabolism of drugs
* metrectomy surgery
* desexualization
* tubal ligation
* menopause
* pregnancy
* not able to use contraception
* drink alcohol more than 14 units/week
* smoker who smokes 10 or more cigarettes

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes